The Prone to Supine Breast MRI Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Number of Successful Segmentation of Supine MRI Images
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to determine whether a supine MRI obtained immediately after a standard diagnostic prone MRI exam, without a second injection of gadolinium (Gd) contrast material, would be of sufficient quality to allow the Radiologist to define the tumor edges ("segment" the tumor) so that a 3-D image of the tumor can be generated to form a BCL.
Detailed Description
The purpose of this study is to find out whether additional MRI images taken with patients in a different position after completing a standard MRI are of sufficient quality to allow a radiologist to identify the edges of the tumor. These additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.The information gathered in this study will make it more feasible to use a new device called the "breast cancer locator" to help surgeons more accurately remove breast cancers.
Investigators
Timothy B. Rooney
MD
Dartmouth-Hitchcock Medical Center
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years.
- •Female gender.
- •Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ
- •Tumor size at least 1 cm in diameter as visualized on mammogram or US.
- •A diagnostic breast MRI is considered to be clinically indicated.
- •Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.
Exclusion Criteria
- •Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes.
- •Severe claustrophobia.
- •Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (eGFR \< 30 ml/min/1.73m2).
- •History of median sternotomy.
- •Pregnancy. Patient attestation that they are not pregnant will be acceptable.
- •Patients who have received neoadjuvant chemotherapy.
Outcomes
Primary Outcomes
Number of Successful Segmentation of Supine MRI Images
Time Frame: 30 minutes
Determine what number of cases that can be successfully segmented both from using post-contrast prone MRI images and also from using post contrast supine MRI images.
Secondary Outcomes
- Time to Position and Obtain Supine Images(30 Minutes)
- Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor(30 minutes)
- Enhancement Quantification- Tumor-to-Background Ratio(30 minutes)
- Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary(30 minutes)
- Overall Comfort for Prone and Supine Positions(Within 15 minutes of the scan)